Neurovalens, the Belfast-based neuro-technology company, has been granted approval by the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for weight management.
The medical device firm’s Modius technology uses low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions such as the management of sleep, anxiety and overall metabolic health.
Related: FDA clears HeartBeam’s at-home arrhythmia assessment tool
Modius Lean is specifically designed the help people manage their weight by delivering a small and safe electrical pulse to the brain for a period of 60 minutes before bed, during which users can do other activities such as watching TV or reading.
FDA medical device De Novo approval was secured following a pivotal clinical trial carried out across the US and UK, with the UK site overseen by Ulster University.
The study included 241 overweight and obese adults and found that participants who used Modius Lean experienced a clinically meaningful reduction of 13% in visceral fat over six months preserving lean muscle mass.
The FDA regulates the development, manufacturing, authorisation, distribution and sale of medical devices in the US across multiple product categories.
Being granted via FDA De Novo approval means the Modius Lean device can now be sold directly to people across the US who have a prescription from their doctor.
Neurovalens has previously obtained medical device clearance from the FDA for its Modius Sleep device for treating insomnia and the Modius Calm device for managing anxiety. Both devices are now being prescribed by healthcare professionals in the US.
“Receiving an FDA De Novo approval for Modius Lean is a significant milestone for Neurovalens, one which takes us back to the original mission of the company,” said Dr Jason McKeown, co-founder of Neurovalens.
Neurovalens, the Belfast-based neuro-technology company, has been granted approval by the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for weight management.
The medical device firm’s Modius technology uses low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions such as the management of sleep, anxiety and overall metabolic health.
Modius Lean is specifically designed the help people manage their weight by delivering a small and safe electrical pulse to the brain for a period of 60 minutes before bed, during which users can do other activities such as watching TV or reading.
FDA medical device De Novo approval was secured following a pivotal clinical trial carried out across the US and UK, with the UK site overseen by Ulster University.
The study included 241 overweight and obese adults and found that participants who used Modius Lean experienced a clinically meaningful reduction of 13% in visceral fat over six months preserving lean muscle mass.
The study’s findings have been published in Nature’s Scientific Reports Journal.
The FDA regulates the development, manufacturing, authorisation, distribution and sale of medical devices in the US across multiple product categories.
Being granted via FDA De Novo approval means the Modius Lean device can now be sold directly to people across the US who have a prescription from their doctor.
Neurovalens has previously obtained medical device clearance from the FDA for its Modius Sleep device for treating insomnia and the Modius Calm device for managing anxiety. Both devices are now being prescribed by healthcare professionals in the US.
“Receiving an FDA De Novo approval for Modius Lean is a significant milestone for Neurovalens, one which takes us back to the original mission of the company,” said Dr Jason McKeown, co-founder of Neurovalens.
“At a time when studies estimate three in four adults in the US are considered overweight or have obesity, and that rate is predicted to keep rising, Modius Lean offers a low-risk, non-invasive, therapeutic alternative to weight loss drugs and dangerous crash diets.
“By targeting harmful visceral fat, Modius Lean has the potential to improve body composition, leading to better metabolic outcomes and improved health and quality of life.
“Neurovalens is focused on achieving continued growth in the US market, and adding the Modius Lean to our suite of certified medical devices moves us further towards that goal.”
Dr Paul D McGeoch, co-founder of Neurovalens, said: “Obesity was the first major health challenge that Jason and I set out to address using non-invasive neurostimulation of key brain areas.
“A robust randomised controlled trial shows that our approach produces a significant reduction in visceral fat in overweight and obese patients.
“This is the type of fat that drives many of the diseases associated with obesity, and I’m proud that Neurovalens has the first and only device in a new FDA category for non-invasive neurostimulation in weight management – a truly unique, neuroscience-driven technology to help patients.”
To date, Neurovalens has raised approximately £20m in equity and debt funding from UK investors, including Wharton Asset Management, IQ Capital, Techstart Ventures, ACF Investors, Beltrae Partners, Investment Fund for Northern Ireland, Clarendon Fund Managers, Whiterock, Innovation Ulster Ltd and British Business Bank.
The company continues to run clinical trials on the effectiveness of its drug-free non-invasive technology in treating other conditions and has approvals pending for the treatment of PTSD.
